(156 days)
Not Found
No
The summary describes a video endoscopy system with image processing capabilities (WLI and NBI modes, 3D observation) but does not mention any AI or ML algorithms for image analysis, diagnosis, or other functions. The performance studies focus on technical aspects and image quality, not AI/ML performance metrics.
Yes
The device is intended for "treatment" and "endoscopic surgery," indicating a therapeutic purpose. It provides visualization during surgical procedures, aiding in the execution of therapeutic interventions.
Yes
The device is intended for "endoscopic diagnosis" and "examination, diagnosis, and visualization of treatment." This directly indicates its use in diagnosing medical conditions.
No
The device description clearly outlines hardware components such as a video system center with processor and light source functions, and a video telescope with a lens system and imager. While software is involved in image processing and display, the device is fundamentally a hardware system with integrated software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the system is for "endoscopic diagnosis, treatment, and video observation" and "endoscopy and endoscopic surgery within the thoracic and abdominal cavities". This involves direct visualization and intervention within the body.
- Device Description: The description details a video system center and video telescope designed to capture and display images from within the body. It describes optical signals, CCD chips, and image processing for visualization.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or treatment. This device does not perform any analysis on biological specimens.
The device is an endoscopic imaging system used for direct visualization and surgical procedures within the body, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
OLYMPUS OTV-S300
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3D WA50080A, WA50082A
This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs. The device is also indicated for visualization during transanal and transvaginal natural orifice surgery.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, HET, GCM, FET, NWB
Device Description
The subject VISERA ELITE II consists of the following primary components:
- VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S300
- VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3D WA50080A/ WA50082A
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical signals transduced into electrical signals.
Anatomical Site
thoracic and abdominal cavities including the female reproductive organs; transanal and transvaginal natural orifice surgery.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Risk analysis: Risk analysis for the OTV-S300 and the WA50080A/ WA50082A was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of the risk analysis assessment.
- Reprocessing validation testing: Reprocessing instruction and reprocessing method validation testing for the WA50080A/WA50082A were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
- Biocompatibility testing: Biocompatibility testing for the WA50080A/WA50082A were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- in vitro cytotoxicity
- irritation
- acute systemic toxicity
- material mediated pyrogenicity
- dermal sensitization test in guinea pigs Magnusson and Kligman (M&K)
- Software verification and validation testing: Software verification and validation testing for the he OTV-S300 and the WA50080A/WA50082A was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
- Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing was conducted on the OTV-S300 and the WA50080A/WA50082A. The system complies with the ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
- Performance testing - Bench: Bench testing for the OTV-S300 and the WA50080A/WA50082A as listed below was conducted to ensure that the subject device performs as intended and meets design specifications.
[OTV-S300]
- Difference for Emergency Lamp (to ensure non-failure LEDs will function as emergency lights)
- NBI Observation
- Observation function
- Image Quality, including:
- Brightness
- Image Intensity
- Color Performance
- Signal to Noise ratio
- Usability
[WA50080A/ WA50082A]
- Real-use contamination
- Field of View
- Design Validation/Usability
- Evaluation of optical properties incl. comparison of optical system properties and image quality (predicate vs. subject devices)
- Thermal Safety
- Surfaces and Edges
- Working Length
- Evaluation of ghost effect
- Evaluation of still image
- Distortion
- Resolution
- Evaluation of performance after reprocessing
- Evaluation of illumination performance
- Mechanical stress resistance (bending/impact)
[OTV-S300 and WA50080A/ WA50082A]
- Photobiological safety
- Performance testing - Animal: No animal study was performed to demonstrate substantial equivalence.
- Performance testing - Clinical: No clinical study was performed to demonstrate substantial equivalence.
Key results: Based on the performance testing the OTV-S300 and the WA50080A/WA50082A are as safe and effective and are substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
April 3, 2020
Olympus Medical Systems Corp. Lisa Boyle Regulatory Affairs Specialist II Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Re: K193026
Trade/Device Name: VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S300, VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3D WA50080A, WA50082A Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ, HET, GCM, FET, NWB Dated: February 25, 2020 Received: February 28, 2020
Dear Lisa Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Jason Roberts, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K193026
Device Name VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S300 VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3D WA50080A, WA50082A
Indications for Use (Describe)
OLYMPUS OTV-S300
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3D WA50080A, WA50082A
This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the the a female reproductive organs. The device is also indicated for visualization during transanal and transvaginal natural orifice surgery.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in a bold, sans-serif font. The word is in a dark blue color. There is a thin, horizontal yellow line underneath the word. The registered trademark symbol is located to the right of the word.
April 3, 2020
510(k) Summary
5.1 GENERAL INFORMATION
- 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
- Contact Person: Lisa M. Boyle Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3676 Fax: 484-896-7128 Email: 1isa.boyle@olympus.com
5.2.1 DEVICE IDENTIFICATION
| ■ Device Name | VISERA ELITE II VIDEO SYSTEM CENTER |
|---|---|
| ■ Model Name | OLYMPUS OTV-S300 |
| ■ Common Name | ENDOSCOPIC IMAGING SYSTEM |
| ■ Regulation Number | 876.1500 |
| ■ Regulation Name | Endoscope and accessories |
| ■ Regulatory Class | II |
| ■ Product Code | FET; Endoscopic Video Imaging System/Component, |
| Gastroenterology-Urology | |
| NWB; Endoscope, Accessories, Narrow Band Spectrum | |
| ■ Manufacturing site | Shirakawa Olympus Co., Ltd. |
| 3-1 Okamiyama, Odakura, Nishigo-mura, | |
| Nishishirakawa-gun, Fukushima 961-8061, Japan |
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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly stylized, with a slight gradient effect. There is a thin yellow line underneath the word. The registered trademark symbol is located to the right of the word.
K193026
Page 2 of 12
5.2.2 DEVICE IDENTIFICATION
| ■ Device Name | VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3D |
|---|---|
| ■ Model Name | WA50080A, WA50082A |
| ■ Common Name | ENDOSCOPIC IMAGING SYSTEM |
| ■ Regulation Number | 876.1500 |
| ■ Regulation Name | Endoscope and accessories |
| ■ Regulatory Class | II |
| ■ Product Code | GCJ; Laparoscope, General & Plastic surgery |
| HET; Laparoscope, Gynecologic (And Accessories) | |
| GCM; Endoscope, Rigid | |
| NWB; Endoscope, Accessories, Narrow Band Spectrum | |
| ■ Manufacturing site | Olympus Winter & Ibe GmbH |
| Kuehnstr.61, | |
| 22045 Hamburg, Germany |
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Image /page/5/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly rounded and have a three-dimensional effect. The word is positioned horizontally and takes up most of the frame. There is a thin yellow line below the word.
5.3 PREDICATE DEVICE
| • Predicate device of OTV-S300 | ||
|---|---|---|
| Primary Predicate Device 1 | ||
| Device name | 510(k) Submitter | 510(k) No. |
| OLYMPUS OTV-S190 | OLYMPUS MEDICAL | |
| SYSTEMS CORP | K111425 | |
| Additional Predicate Device 2 | ||
| Device name | 510(k) Submitter | 510(k) No. |
| OLYMPUS CLV-S190 | OLYMPUS MEDICAL | |
| SYSTEMS CORP | K111425 | |
| Additional Predicate Device 3 | ||
| Device name | 510(k) Submitter | 510(k) No. |
| MAJ-Y0154 | OLYMPUS MEDICAL | |
| SYSTEMS CORP | K123365 |
● Predicate device of WA50080A, WA50082A
| Primary Predicate Device 1 | ||
|---|---|---|
| Device name | 510(k) Submitter | 510(k) No. |
| WA50050A/52A | Olympus Winter& Ibe GmbH | K190744 |
5.4 Recalled Predicate (K111788)
The Endoeye HD II Video Telescope cleared in predicate K111788 was the subject of a class II design related recall due to a damaged temperature sensor in the distal end of the endoscope. The issue has been successfully resolved and design changes have been cleared via K190744.
The installed heating element warms the distal tip to minimize or eliminate fogging of the lens during the procedure and aids in the prevention of endoscope removal to clean the lens due to fogging during a procedure. The ENDOEYE 3D does not include this feature.
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Image /page/6/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are a sans-serif font and are evenly spaced. There is a yellow line underneath the word, which appears to be a design element. The registered trademark symbol is located to the right of the word.
5.5 DEVICE DESCRIPTION
● General Description of the subject device
The subject VISERA ELITE II consists of the following primary components:
- VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S300
- VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3D WA50080A/ WA50082A
• Principle of Operation
The fundamental technology for the 3D function is identical to the predicate device.
A) VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTY-S300
The subject device has both a processor function and light source function. By switching on the illumination lamp in the subject device provides light through the endoscopes directly for endoscopic observation.
This device also constantly regulates the endoscopic image brightness from the video system center. The observation mode can be switched by the optical filter and LED extracting the specific wavelengths. There are two modes: WLI (White light imaging) mode for normal observation and NBI (Narrow-band imaging) mode for an optical image enhancement technology.
By driving the CCD equipped in the endoscopes, the images are transduced into electrical signals from the optical signals, and the subject device displays the endoscopic images on the monitors.
B) VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3DWA50080A/ WA50082A
The subject devices are designed to transfer optical images from a body cavity via a lens system directly to an imager for further electrical signal transmission to a video processor. The video telescope is designed for examination, diagnosis, and visualization of treatment (treatment can only be performed by using endoscopic accessories in combination). For illumination of body cavities, the transfer of light from a supply unit to the body cavity is achieved by means of a light guide. The subject device, ENDOEYE 3D, is a design variant of the predicate ENDOEYE HD II video endoscope offering a 3D observation mode. The 3D effect enables the surgeon to perceive significant spatial information which is beneficial in terms of optimized speed, accuracy and precision of surgical procedures by users of all skill levels. It may also shorten the learning curve for surgical tasks.
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Image /page/7/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, and the word is centered in the image. Below the word "OLYMPUS" is a thin, horizontal, yellow line. The background of the image is white.
The ENDOEYE 3D is used with a 3D video system and a 3D monitor with dedicated polarization glasses.
For laparoscopic applications, the video telescope is inserted via a trocar into the patient.
The ENDOEYE 3D is used with a video system center, light source and monitor to achieve its intended function.
In addition, the ENDOEYE 3D can be placed in compatible instrument trays for reprocessing.
The ENDOEYE 3D can provide an image with either white light or narrow band imaging.
5.6 INDICATIONS FOR USE
A) VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S300
This video system center is intended to be used with OLYMPUS camera heads. endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
B) VISERAELITE II VIDEO TELESCOPE ENDOEYE 3D WA50080A/ WA50082A
This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
The device is also indicated for visualization during transanal and transvaginal natural orifice surgery.
The ENDOEYE 3D has the same indication of use as the predicate device except for the addition of the last sentence regarding visualization of transanal and transvaginal applications. This difference does not represent a different intended use.
510(k) Summary Page 5 of 12
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5.7 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE
The VISERA ELITE II has the same technological characteristics and design as the predicate device except for the following new features:
-Integration of the video processor, light source, and 3D mixer (OTV-S300)
-New integrated video connector into one for 3D observation
-New LED construction
- -No fog free function
The detailed comparison chart between subject device and predicate devices are as following.
510(k) Summary Page 6 of 12
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K193026 Page 7 of 12 Traditional 510(k) Notification VISERA ELITE II VIDEO SYSTEM CENTER, TELESCOPE
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Device Comparison Table of OTV-S300
| |
OTV-S300 |
OTV-S190 |
CLV-S190 |
MAJ-Y0154
3D PROCESSOR |
|----------------------------|------------------------------|---------------------------------------------|------------------------------------------------|-----------------------------------------------------------------|
| 510(k)
Number | K193026 | K111425 | K111425 | K123365 |
| Rated voltage | 100V AC
50/60Hz | 100V AC
50/60Hz | 100V AC
50/60Hz | 100V AC
50/60Hz |
| Rated input | 400VA | 150VA | 500A | 100VA |
| Dimension
(maximum) | W383×H199×D506
(mm) | W382×H91×D489
(mm) | W383×H162×D536
(mm) | W375×H91×D478
(mm) |
| Weight | 19.3kg | 8.8kg | 14.9kg | 7.7kg |
| AGC (Auto
gain control) | Provided | Provided | Provided | Not provided |
| 3D observation | Provided | Not provided | Not provided | Provided |
| Front panel
(Operation) | Touch panel | Push button | Push button | Push button |
| Examination
Lamp | LED | Not provided | Xenon lamp | Not provided |
| NBI | Provided | Provided | Provided | Not provided |
10
K193026 Traditional 510 € Notification VISERA ELITE II VIDEO SYSTEM CENTER, TELESCOPE
Image /page/10/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced and have a slight 3D effect. There is a registered trademark symbol to the right of the word. A yellow bar is located underneath the word.
| |
WA50080A, WA50082A |
WA50050A/52A |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K193026 | K190744 / K111788 |
| Outer diameter
of insertion
tube (distal
end) | WA50080A: max.10.07 mm
WA50082A: max.10.20 mm | WA50050A: max. 5.45 mm
WA50052A: max. 5.45 mm |
| Maximum
working
length | WA50080A: 330 mm
WA50082A: 335 mm | WA50050A: 300.5 mm
WA50052A: 303 mm |
| Direction of
view (DOV) | WA50080A: 0°
WA50082A: 30° | WA50050A: 0°
WA50052A: 30° |
| NBI
observation | Compatible | compatible |
| Field of view
(FOV) | Both models: 67° ± 9° | Both models: 80.4° ± 8° |
| Depth of field | 25 to 120 mm | 21 to 200 mm |
| Type of CCD
chip | Color CCD | Color CCD |
| | | |
| | WA50080A, WA50082A | WA50050A/52A |
| Number of CCD chip | 2 | 1 |
| 2D function | Available | Available |
| 3D function | The video telescope can transmit 2D images and 3D images to the video system center. The video telescope is equipped with a second image sensor inside the distal end to create 3D images that can be viewed on compatible video system centers and video monitors using compatible 3D glasses. | The video telescope can only transmit 2D images to the video system center. A 3D image sensor is not included and therefore; no 3D mode is offered. |
Device Comparison Table of WA50080A, WA50082A
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12
All other technological characteristics of both the subject and predicate devices are identical. The differences in technological characteristics noted in the tables do not raise different questions of safety and effectiveness.
5.8 PERFORMANCE DATA
1) Risk analvsis
Risk analysis for the OTV-S300 and the WA50080A/ WA50082A was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of the risk analysis assessment.
The following performance data is provided in support of the substantial equivalence determination.
2) Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing for the WA50080A/WA50082A were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
3) Biocompatibility testing
Biocompatibility testing for the WA50080A/WA50082A were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- in vitro cytotoxicity
- irritation i
- acute systemic toxicity ।
- material mediated pyrogenicity i
- dermal sensitization test in guinea pigs Magnusson and Kligman (M&K) ।
13
4) Software verification and validation testing
Software verification and validation testing for the he OTV-S300 and the WA50080A/WA50082A was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
5) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing was conducted on the OTV-S300 and the WA50080A/WA50082A. The system complies with the ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
6) Performance testing - Bench
Bench testing for the OTV-S300 and the WA50080A/WA50082A as listed below was conducted to ensure that the subject device performs as intended and meets design specifications.
[OTV-S300]
- Difference for Emergency Lamp (to ensure non-failure LEDs will functionas emergency lights)
- NBI Observation
- Observation function
- Image Quality, including:
- · Brightness
- · Image Intensity
- Color Performance
- · Signal to Noise ratio
-Usability
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[WA50080A/ WA50082A]
- Real-use contamination
- Field of View
- Design Validation/Usability
- Evaluation of optical properties incl. comparison of optical system properties and image quality (predicate vs. subject devices)
- Thermal Safety
- Surfaces and Edges
- Working Length
- Evaluation of ghost effect
- Evaluation of still image
- Distortion
- Resolution
- Evaluation of performance after reprocessing
- Evaluation of illumination performance
- Mechanical stress resistance (bending/impact)
[OTV-S300 and WA50080A/ WA50082A]
- Photobiological safety
7) Performance testing - Animal
No animal study was performed to demonstrate substantial equivalence.
8) Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
59 CONCLUSIONS
Based on the performance testing the OTV-S300 and the WA50080A/WA50082A are as safe and effective and are substantially equivalent to the predicate device.